US regulators on Monday put an experimental immunotherapy agent on the fast track to market approval, after 89 percent of leukemia patients in early trials saw their cancers disappear.
The personalized immunotherapy, CTL019, was developed by the University of Pennsylvania and was designated a “breakthrough therapy” by the US Food and Drug Administration (FDA).
That means the experimental therapy will benefit from a speedier-than-average review process and is to get extra attention from the FDA toward development for the market.
It is the first cancer immunotherapy to receive the breakthrough designation, and only the fifth biologic agent so far. The approach works by extracting a patient’s T-cells, then genetically programming them in the lab to target cancer cells that produce a protein called CD19.
The altered T-cells are then reinjected into the patient’s body, where they multiply and attack cancer.
Researchers reported last year that of 27 patients — 22 children and five adults — with acute lymphoblastic leukemia, 89 percent had a complete response to the therapy, meaning their cancer became undetectable.
The first child to receive the treatment, Emily Whitehead, in May marked two years of being in remission, and the first adult patient has been in remission for a year.
“Our early findings reveal tremendous promise for a desperate group of patients, many of whom have been able to return to their normal lives at school and work after receiving this new, personalized immunotherapy,” said Carl June, the Penn research team’s leader.
The university in 2012 teamed up with pharmaceutical company Novartis AG to develop and license personalized chimeric antigen receptor T-cell therapies for the treatment of cancers.
In addition to the ongoing trials for acute lymphoblastic leukemia, trials using CTL019 began in the summer of 2010 in patients with relapsed and refractory chronic lymphocytic leukemia.
It is also being tried in patients with non-Hodgkin’s lymphoma and myeloma.
More research is also under way into chimeric antigen receptor therapies for mesothelioma, ovarian, breast and pancreatic cancers.
Taiwan’s foreign exchange reserves fell below the US$600 billion mark at the end of last month, with the central bank reporting a total of US$596.89 billion — a decline of US$8.6 billion from February — ending a three-month streak of increases. The central bank attributed the drop to a combination of factors such as outflows by foreign institutional investors, currency fluctuations and its own market interventions. “The large-scale outflows disrupted the balance of supply and demand in the foreign exchange market, prompting the central bank to intervene repeatedly by selling US dollars to stabilize the local currency,” Department of Foreign
Intel Corp is joining Elon Musk’s long-shot effort to develop semiconductors for Tesla Inc, Space Exploration Technologies Corp and xAI, marking a surprising twist in the chipmaker’s comeback bid. Intel would help the Terafab project “refactor” the technology in a chip factory, the company said on Tuesday in a post on X, Musk’s social media platform. That is a stage in the development process that typically helps make chips more powerful or reliable. The chipmaker’s shares jumped 4.2 percent to US$52.91 in New York trading on Tuesday. The Terafab project is a grand plan by Musk to eventually manufacture his own chips for
Taiwan Power Co (Taipower, 台電) yesterday said it plans to resume operations at two coal-fired power generators for three months to boost security of electricity supply as liquefied natural gas (LNG) supply risks are running high due to the Middle East conflict. The two coal-fired power generators are at Mailiao Power Plant in Yunlin County’s Mailiao Township (麥寮). The plant, operated by Formosa Plastics Group (台塑集團), supplied electricity to Taipower’s power grid until the end of last year. Taipower’s decision came about one month after Minister of Economic Affairs Kung Ming-hsin (龔明鑫) on March 10 said that the nation had no imminent
Some robotaxi passengers were left stranded in the middle of fast-moving traffic in a major Chinese city after their driverless vehicles stopped running, according to police and media reports on Wednesday. A preliminary investigation indicates more than 100 robotaxis came to a halt because of a “system malfunction,” police in the city of Wuhan said in a statement, without elaborating. No injuries were reported. One passenger told Chinese media that their robotaxi stopped after turning a corner. An instruction on a screen read: “Driving system malfunction. Staff are expected to arrive in 5 minutes.” After no one showed up, the passenger pushed
RSS